(708e) Production of Pharmaceutical Tablets By FDM 3D Printing

Novak, M., ICT Prague
Zadrazil, A., University of Chemistry and Technology
Stepanek, F., University of Chemistry and Technology
Kovacik, P., Prague Institute of Chemical Technology

Production of pharmaceutical
tablets by FDM 3D printing

Production of tablets using 3D printers is a novel
method of pharmaceutical formulation. Although still in the
research&development phase, since recently it already has its first
commercial application. The main advantage of this approach is that every
single tablet can be printed to meet the needs of a specific patient, the
dosage and dissolution rate can be controlled by the composition and porosity
of the tablet. Furthermore, two or more drugs can be present in one tablet by
using multiple printer nozzles with varying feed materials. The topic of
this work is fabrication of pharmaceutical tablets, using Fused Deposition
Modeling (FDM), a commercially available 3D printing technology, which utilizes
thermoplastic polymer filaments as feed material. Biodegradable filaments were
produced from mixtures of pharmaceutical polymers with additions of
plasticizers and defined contents of a model drug, processed by hot-melt
extrusion. For this purpose, the DIY hot-melt extruder Filastruder v1.5
was employed, which surpassed standard pharmaceutical extruders in terms of
price, maintenance time and replaceability of its components, making it ideal
for the purposes of an extensive parametric study of filament composition. This
study resulted in production of drug-laden filaments with mechanical properties
suitable for 3D printing, which were then successfully used as feed material for
FDM 3D printer to produce tablets of varying shape and porosity. Furthermore,
the effect of various printing parameters on the quality of the printed tablets
was documented. Composition analysis by HPLC has confirmed that the drug
contents in the tablets correspond with the initial drug loadings of the
filaments. XRPD and DSC analyzes have shown, that the drug in the tablets
exists in the form of an amorphous solid solution. Dissolution analysis has
illustrated the effect of tablet shape, porosity and printing settings on the
dissolution profile.

Although some cases of 3D printed tablets through Fused
Deposition Modeling were already reported in the past, to the best knowledge of
the author, this work presents the only case, where a conventional drug (with a
relatively low melting point), which did not contribute to the printability of
the material, was processed. Also, the extrusion and printing temperature is
the lowest achieved so far in the field of FDM tablet printing. This makes the
documented method more universal (applicable for a wider range of drugs) and
presents potential for future research, which will involve incorporation of
multiple drugs into one tablet, increasing resolution of the printing and
expanding control over dissolution behavior.

a) A disc-shaped tablet with
deformations, resulting from using an unsuitable model, b) A disc-shaped tablet from a more suitable model, printed with a
slight drop-shaped deformation on one side, c) A disc-shaped tablet from the same model as b), but with no
deformation (due to better printing settings), d) A caplet-shaped tablet, e) A
caplet-shaped tablet with micropores (pore height of 0.6 mm), which were most
probably at least partially clogged during dissolution due to the slight
swelling of the tablet, f) A
caplet-shaped tablet with larger pores (pore height of 1.2 mm), which most
probably stayed at least partially open during dissolution, which explains the
highest dissolution rate of this tablet

a) A biodegradable
drug-laden filament, suitable for 3D printing purposes, b) A cylinder-shaped tablet,

c) A caplet-shaped tablet
with predefined partially visible micropores